Plain English Summary
http://www.cancerhelp.org.uk/trials/a-trial-looking-at-chemotherapy-for-testicular-cancer
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00324298
Protocol/serial number
Version 4.1
Study information
Scientific title
A randomised phase III toxicity study of day 2, 8, 15 short (30 minute) versus day 1, 2, 3 long (72 hours) infusion bleomycin for patients with International Germ Cell Cancer Collaborative Group (IGCCCG) good prognosis germ cell tumours, TE3
Acronym
TE3
Study hypothesis
This study aims to ascertain whether administering the same total dose of bleomycin by a continuous 72-hour infusion over the first three days of chemotherapy results in lower lung toxicity than if administered conventionally as weekly bolus injections.
On 22/04/2010 this record was updated to coincide with protocol version 4.1 (previous protocol version 3 was registered); all changes can be found in the relevant fields:
1. The anticipated end date was changed from 31/12/2009 to 30/09/2010.
2. The target number of participants was also changed from 210 to 212.
On 15/02/2011 the anticipated end date was changed from 30/09/2010 to 30/03/2011.
Ethics approval
Northern and Yorkshire Multi-Centre REC, 10/07/2003
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
IGCCCG Good Prognosis Germ Cell Tumours
Intervention
Day 2, 8, 15 short (30 minute) versus day 1, 2, 3 long (72 hours) infusion bleomycin.
In addition to standard care for patients on chemotherapy, which includes biochemical and radiological evaluation of disease, patients will also undergo lung function testing and computed tomography (CT) to assess pulmonary toxicity.
Intervention type
Drug
Phase
Phase III
Drug names
Bleomycin
Primary outcome measure
Pulmonary toxicity, as confirmed by central radiological review of CT scans at 12 weeks after starting treatment
Secondary outcome measures
1. CT scan changes at 6 weeks
2. Quality of life
3. Changes in respiratory function tests
4. Treatment response
5. Progression-free and overall survival
Overall trial start date
08/07/2003
Overall trial end date
30/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients aged 16 - 50 inclusive
2. Patients with proven good risk metastatic germ cell cancer of the testis
3. Patients eligible for treatment with bleomycin, etoposide and cisplatin
4. Patients who are able to understand their participation in the study and give written consent
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
212
Participant exclusion criteria
1. Patients who have had previous radiotherapy and/or chemotherapy
2. Patients with creatinine clearance less than 60 ml/min
3. Patients with a previous or concurrent second malignancy, except for basal cell skin cancer
4. Patients with any other major systemic illness
5. Impaired respiratory function i.e. shortness of breath on minimal exertion or hypoxia at rest, transfer coefficient for carbon monoxide (KCO), total lung capacity (TLC), forced expiratory volume in one second (FEV1) less than or equal to 60% predicted
Recruitment start date
08/07/2003
Recruitment end date
30/03/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Medical Oncology
London
EC1A 7BE
United Kingdom
Sponsor information
Organisation
Barts and The London NHS Trust (UK)
Sponsor details
Joint R&D Department
Barts & The London NHS Trust
Rutland House
New Road
London
E1 2AX
United Kingdom
+44 207 882 7260
gerry.leonard@bartsandthelondon.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Orchid Cancer Appeal (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list